ANDA 079025

EMCURE PHARMS LTD

FDA Drug Application

Application #079025

Application Sponsors

ANDA 079025

EMCURE PHARMS LTD

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	TABLET;ORAL	10MG;12.5MG	0	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE
002	TABLET;ORAL	20MG;12.5MG	0	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE

FDA Submissions

	ORIG	1	AP	2010-09-17
LABELING; Labeling	SUPPL	4	AP	2020-08-20	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	4	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

EMCURE PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 79025
            [companyName] => EMCURE PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE","activeIngredients":"FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE","strength":"10MG;12.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE","activeIngredients":"FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE","strength":"20MG;12.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE","submission":"FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE","actionType":"10MG;12.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE","submission":"FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE","actionType":"20MG;12.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)